3M Bair Hugger 675 Manual Del Operador página 7

Proper Use and Maintenance
3M assumes no responsibility for the reliability, performance, or
safety of the temperature warming unit if the following events occur:
• Modifications or repairs are not performed by a qualified, medical
equipment service technician who is familiar with good practice
for medical device repair�
• The unit is used in a manner other than that described in the
Operator's or Preventive Maintenance Manual�
• The unit is installed in an environment that does not provide
grounded electrical outlets�
• The warming unit is not maintained in accordance with the
procedures described in the Preventive Maintenance Manual
Diagnostics
A qualified service technician can perform over-temperature
detection system testing, temperature output testing, operating
temperature calibration, and error/fault code troubleshooting�
Read Before Servicing Equipment
All repair, calibration, and servicing of the temperature warming unit
require the skill of a qualified, medical equipment service technician
who is familiar with good practice for medical device repair� (No
further 3M warming unit-specific special training, licensing or
certification required for servicing of Model 675 warming unit�) If
service does not require the manufacturer's attention, the Model 675
Preventive Maintenance Manual provides the technical information
needed to service the unit� Perform all repairs and maintenance
in accordance with the instructions in the Model 675 Preventive
Maintenance Manual For additional service information please
contact 3M Technical Support�
In-Warranty Repair and Exchange
USA:
• Call 3M at 1-800-228-3957 if your Model 675 warming unit
requires factory service�
• Provide the serial number located on the back of the warming
unit�
• Technical Support will give you a Return Authorization (RA)
number� Use this RA number on all correspondence� Your
Technical Support representative will also send a shipping carton
to you at no charge, if needed�
Outside of the USA:
Contact your local distributor concerning in-warranty repair and
exchange� Provide the serial number located on the back of the Bair
Hugger warming unit when you call�
PLEASE REPORT A SERIOUS INCIDENT OCCURRING
IN RELATION TO THE DEVICE TO 3M AND THE
LOCAL COMPETENT AUTHORITY (EU) OR LOCAL
REGULATORY AUTHORITY.
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Symbol Glossary
Symbol Title Symbol Description and Reference
Indicates the medical device
Manufacturer manufacturer� Source: ISO
15223, 5�1�1
Indicates the authorized
Authorized
representative in the
Representative
European Community /
in European
European Union� Source: ISO
Community /
15223, 5�1�2, 2014/35/EU,
European Union
and/or 2014/30/EU
Indicates the date when
Date of the medical device was
manufacture manufactured� Source: ISO
15223, 5�1�3
Indicates the manufacturer's
catalogue number so that
Catalogue number the medical device can be
identified� Source : ISO 15223,
5�1�6
Indicates the manufacturer's
serial number so that a
Serial number specific medical device can
be identified� Source: ISO
15223, 5�1 �7
Indicates a medical device
that needs to be protected
Keep dry
from moisture� Source: ISO
15223, 5�3�4
Consult instructions
Indicates the need for the user
for use or consult
to consult the instructions for
electronic
use� Source: ISO 15223, 5�4�3
instructions for use
Indicates that caution is
necessary when operating
the device or control close
to where the symbol is
placed, or that the current
Caution
situation needs operator
awareness or operator action
in order to avoid undesirable
consequences� Source: ISO
15223, 5�4�4
Indicates the item is a medical
Medical Device device� Source: ISO 15223,
5�7�7
Indicates a carrier that
Unique device contains unique device
identifier identifier information� Source:
ISO 15223, 5�7�10
Indicates the entity importing
the medical device into the
Importer
locale� Source: ISO 15223,
5�1�8
Safety sign indicating no free
No Free Hosing
hosing
Indicates conformity to
all applicable European
CE Mark Union Regulations and
Directives with notified body
involvement�
Indicates that U�S� Federal
Law restricts this device to
sale by or on the order of a
Rx Only
healthcare professional� 21
Code of Federal Regulations
(CFR) sec� 801�109(b)(1)
Indicates the maximum safe
Maximum safe
working load in less than the
working load
number reported�
Indicates product was
UL Classified evaluated and Listed by UL for
the USA and Canada�
Indicates a financial
contribution to national
packaging recovery company
per European Directive No�
Green Dot
94/62 and corresponding
national law� Packaging
Recovery Organization
Europe�
To signify that the instruction
Refer to instruction manual/booklet
manual/booklet must be read� ISO 7010-
M002
To identify any terminal which
is intended for connection
to an external conductor for
protection against electric
Protective earth
(ground) shock in case of a fault, or the
terminal of a protective earth
(ground) electrode� Source:
IEC 60417, 5019
To identify the terminals
which, when connected
together, bring the various
parts of an equipment or of a
Equipotentiality
system to the same potential,
not necessarily being the
earth (ground) potential�
Source: IEC 60417-5021
Fuse Indicates a replaceable fuse
DO NOT throw this unit into
a municipal trash bin when
this unit has reached the end
Recycle electronic
of its lifetime� Please recycle�
equipment
Source: Directive 2012/19/
EC on waste electrical and
electronic equipment (WEEE)
Indicates vertically falling
drips shall have no harmful
IP Code effects� Source: IEC
60529+AMD1:1999+
AMD2:2013CSV/COR2:2015
To identify a type BF applied
Type BF applied part complying with IEC
part 60601-1� Source: IEC 60417-
5333
Safety sign indicating the Bair
Hugger warming unit Model
Use only
675 has been designed to
3M warming units
operate safely ONLY with
and 3M warming
3M disposable warming
blankets or
blankets and gowns� Use with
gowns together
other products may cause
thermal injury�
Over-temperature Indicates over-temperature
- Stop use: set point has been reached�
Service required Stop use: Service required
Under-temperature The under-temperature set
- Stop use: point has been reached�
Service required Stop use: Service required
Indicates that after current
Filter time limit has
use, the filter should be
been reached
changed by service personnel
Power button Color indicates the
(power indicator) power status�
Ambient air (Room Indicates ambient air (Room
temperature air) temperature air) set point
Stop use: Indicates to stop use and
Service required service is required
For more information see, HCBGregulatory.3M.com
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